Food allergy is a serious and growing public health issue. Recent data suggest that approximately 15 million Americans have food allergies, including one in every 13 children. Every three minutes, a food allergy reaction sends someone to the emergency room. The U.S. Centers for Disease Control report that food allergies result in more than 300,000 ambulatory-care visits a year among children under the age of 18.
The most serious reaction to a food allergy is anaphylaxis, an exaggerated immune response that can lead to severe rashes, pronounced swelling, particularly of the throat and tongue, and a precipitous drop in blood pressure that can be fatal. Teenagers and young adults with food allergies are at the highest risk of fatal food-induced anaphylaxis.
Eight foods account for 90 percent of all reactions: Milk, eggs, peanuts, tree nuts, soy, wheat, fish, and shellfish. Even trace amounts of a food allergen can cause a reaction.
“Currently, the FDA is weighing the issue of preventive controls and food allergen thresholds—matters of great importance to the food allergy community,” says John Lehr, CEO of the nonprofit advocacy organization, Food Allergy Research & Education (FARE), McLean, Va. “In January, the FDA requested public comment on a new proposed rule on preventive controls called Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. It would improve safety across the food system by reducing the risks from all hazards in manufactured foods.”
The regulations would include specific requirements for preventing the unintended presence of allergens, generally referred to cross-contact, including requiring companies to identify areas of concern and to implement plans to prevent cross-contact.
Another major issue of concern is the mislabeling of food. “Prior to 2004, there was no requirement in the law specifically requiring that food allergens be labeled,” says Lehr. “Then with the passage of the Food Allergen and Labeling Consumer Protection Act (FALCPA) by Congress, companies were required to declare the eight major allergens.” However, Lehr points out, even though the legislation has been in place for several years, there are still recalls for undeclared allergens, “So there is still a significant problem.”
Helping to address the problem, FARE offers a website with a list of resources for industry, and for members of the food allergy community. “We also have staff members who address industry groups on a regular basis, speaking to employees about the food allergic consumer’s perspective,” says Lehr. “We also host the annual meeting of the Food Allergy & Anaphylaxis Alliance, a group of advocacy organizations around the world.” This year’s meeting, which will be held in early October, includes an industry day that brings together regulatory officials, representatives of the food industry, and allergy advocates to discuss issues in food allergy safety.
Even trace amounts of a food allergen can cause a reaction.
Establishment of Thresholds Key
“There is a large range in individual threshold doses,” says Steve Taylor, PhD, director of the Food Allergy Research and Resource Program, University of Nebraska-Lincoln. “If you just look at peanut allergy alone, some people have to eat several peanuts, or a hand full to get sick. Other people would react to small specks.” For specific measures of what induces an allergic reaction there is enough published data out there, Dr. Taylor thinks, to get a consensus on how much is too much—insofar as food production is concerned—and how that threshold, or reference dose should be the industry standard for the detection and prevention of cross-contact.
Yet, precise regulatory guidelines are lacking. “None of the public health agencies have established regulatory reference doses so, in the absence of official action, everybody continues to work towards zero, which of course you can never achieve.”
The big questions remaining for the food and beverage industry are, how do I effectively clean, and further, how can I validate cleaning efficacy? Dr. Taylor points out that the FDA is working on it, and he hopes some standards will be set soon. “The FDA published a threshold notice in the federal register as part of the FALCPA in December of last year, and they sought public input. So, they are certainly seriously considering it.”
Of course some sectors of the food and beverage industry and some types of facilities have a greater risk profile. “Any situation where you have a clean-in-place system, say like, dairy processing, that’s the ideal way to clean up because you can use copious amounts of aqueous fluids to do the cleaning,” says Dr. Taylor. Standards can be programmed in—all you have to do is push the button. “It’s much harder to do in any situation where you have to rely upon dry cleaning. Bakeries are a good example. Baking ovens are only partially accessible, and not easily cleaned.” Ensuring an allergy-free environment in such a case would likely involve the use of laboratory test kits, which are now widely available.
The biggest risk of allergen cross-contact is at your local restaurant. “That’s where most of the more serious reactions occur,” Dr. Taylor says. Foods are not labeled, as they would be in a grocery store, and the server may not really know all the ingredients of a certain dish.
“It’s pretty hectic in those kitchens during the dinner hour—could peanut residue from your entrée end up in mine? Probably. And because of that I know any number of peanut-allergic people who won’t eat in certain kinds of restaurants because they know that the risk is there.”
The biggest risk of allergen cross-contact is at your local restaurant.
Rapid Test Kits
Due to the rising prevalence of allergies to certain foods, and the relatively certainty of new regulatory standards, business in the testing sector is brisk.
“We have different diagnostic kits that you could use yourself in-house,” says Jennifer Baker, a product manager for Neogen, headquartered in Lansing, Mich.
Kits are based on antibody technology, such as enzyme-linked immunosorbent assay, commonly known as ELISAs—these are quantitative. For more “yes or no” type testing there are swipe tests. “These can be done in five minutes, and it lets you know if you cleaned your surface well enough.”
As for the threshold of detection, “the tests have always been sensitive,” says Baker. “In many cases I think the kits are more sensitive than they need to be (since the FDA has yet to set the standards) but that provides an additional layer of security for the food manufacturers.”
While interest in allergen testing has been relatively constant of late, what Baker has noticed is a much greater interest in testing for gluten—a problem not described as an allergy per se, but a sensitivity. “We’re getting inquiries about kits for wheat seed allergen, and also barley and rye. That’s definitely been on the increase since the establishment of the gluten-free market.”
Neogen has also recently developed an assay for mustard. “A Canadian law recently went into effect that states that mustard must be included in labeling, so in the last year we introduced both a quantitative assay and a lateral flow test, we also added a new lateral flow test for sesame, also on the Canadian list.”
Necessity is sometimes the mother of re-invention—take the case of Lara Holland, a certified food allergy and gluten consultant for commercial kitchens based in southern California.
“I grew up with the belief that people with food allergies were just picky eaters,” recalls Holland. All through childhood she could eat anything, but then a serious illness in her twenties changed all that, and the average meal became a minefield.
“I became acutely embarrassed about my food allergies—I didn’t want to talk about it.” It seemed few understood, and fewer still were willing to accommodate what could easily be a life-threatening allergic sensitivity.
In self-defense, Holland set out to get an education. Training as a nutritionist, and then working in commercial kitchens, Holland came to understand the product, and the production line, and became an expert on where the hazards lie. Her focus now is on food service.
“Often times people’s most serious reactions happen inside a restaurant—they encounter the allergen where they have no control.” And hazards can be commonplace. “You tell the server, ‘no nuts’ and the server forgets to write it down, or worse, the line cook doesn’t see it or ignores it, or the dish is premade and the server picks off the nuts and brings it to your table.” An hour later you’re in the hospital.
A second offense is ignorance of ingredients. “You may think the soy sauce is gluten free but often it is not, you may think there’s no garlic in the condiment, but there is…”
For the first offense, Holland can offer an allergy audit of an operation, followed by staff training, online or in person. “For the most part, servers really do care; it’s just that sometimes they have no idea.”
As to the second offense, Holland has, with her nutritionist and restaurant background and the help of a software designer, put together a program tailor-made to each restaurant client, a program that provides an allergy-free menu to the customer and alerts to the kitchen.
The AllerSmart program works like this: All the ingredients for all menu items are input into the program. When the customer says, “I’m allergic to shellfish,” the server enters that information, the program then generates a list of shellfish-free options. Further, the kitchen receives an alert that table six has a shellfish sensitivity, so be extra careful to avoid cross-contact on the prep line.
Holland says reactions to the program are positive. “They tell us that it will save them money on training (staff turnover is generally high) and moreover, minimizes their liability regarding law suits.”
And it’s just plain good for business. “Once you’ve served that person with special needs, they will be forever loyal. We see increases from 8 to 25 percent in revenue with food allergic diners,” comments Holland.
Canavan is a freelance writer based in Brooklyn, N.Y. Reach him at firstname.lastname@example.org.